1-methyl-1-phenylethyl peroxyneodecanoate

Endpoint summary

Description of key information

For 1-Methyl-1-phenylethyl peroxyneodecanoate (target substance), suitable data are available to assess the acute toxicity. In an acute oral in vivo toxicity study conducted similar to OECD 401, Charles River CD rats (5/sex/dose) were orally exposed to 2034, 3229, 5126, 8137 and 12918 mg/kg bw Cumyl peroxyneodecanoate (target substance, 90.2% purity). In this study, the oral LD50 in rats in considered to be 5126 mg/kg bw. In a second available acute oral in vivo toxicity study conducted according to OECD 401, Sprague-Dawley rats were given a single oral dose of TRIGONOX 99-C75 (target substance, 75% purity). In this study, the oral LD50 in rats is considered to be greater than 2000 mg/kg bw.

In an acute inhalation toxicity study similar to OECD 403, Charles River CD rats were exposed by inhalation route to LUPERSOL 188M75 containing 75.5% cumyl peroxyneodecanoate (0.19% Hydro; 896 ppm Cl^-) for 1 hour via whole body exposure at a concentration of 20.4 mg/L. No mortality occurred during the 14-day observation period.

In an acute dermal toxicity study conducted similar to OECD 402, groups of New Zealand White rabbits (three/sex) were dermally exposed to Cumyl peroxyneodecanoate (90.2% purity) for 72 hours at doses of 500, 1250, 3150, 7940 and 19800 mg/kg bw. Based on the results, the dermal LD50 was considered to be within < 19800 and > 7940 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977-09-02 to 1978-02-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Name: Cumyl peroxyneodecanoate (SN-1-4462-71)
- Purity: 90.2%
- Appearance: viscous yellowish liquid

Species:

rat

Strain:

other: Charles River CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, Michigan
- Weight at study initiation: 200 - 248 g
- Housing: Animals were housed by sex in groups of 5 rats per cage in hanging wire-mesh cages
- Water: ad libitum
- Diet: ad libitum; Purina Laboratory Chow (withheld during overnight period preceding oral administration)
- Temperature and humidity controlled quarters

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

once (to male and female): 2034, 3229, 5126, 8137, 12918 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

OBSERVATIONS
- Weighing: Initially, at 7 and 14 days
- Mortality/Viability: During first four hours after dosing, at 24 hours and daily thereafter

Statistics:

Statistical Reference
LD50 values and associated 95% confidence interval, slope of dose mortalitiy curve
References:
- Weil, C.S. 1952. Tables for Convenient Calculation of Median Effective Dose and Instruction in Their Use. Biometrics, 8: 249 - 263
- Thompson, W.R. and Weil, C.S. 1952. On the Construction of Tables for Moving Average Interpolation. Biometrics, 8: 51 - 54
- Eby, R. 1957. Statistical Tables for Dose Evaluation, Report No. 5711. Miles - Ames Research Laboratoy, Elkhart, Indiana

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

4 068 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 132 - <= 5 284

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

6 458 mg/kg bw

Based on:

test mat.

95% CL:

>= 5 590 - <= 7 462

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 126 mg/kg bw

Based on:

test mat.

95% CL:

>= 4 294 - <= 6 118

Mortality:

At 8137 and 12918 mg/kg all animals died. At 5126 mg/kg 4/5 female animals were found dead and at 3229 mg/kg 1/5 female animals died. No deaths occured at a dose of 2034 mg/kg.
For individual results see Table 1 in box 'Any other information on results incl. tables'.

Clinical signs:

No data

Body weight:

A trend in decreasing body weight gain is observed in survived animals.
For individual results see Table 1 in box 'Any other information on results incl. tables'.

Gross pathology:

No data

Table 1: Mortality and LD50 Values

Exposure Conc. mg/kg

Number of Deaths

Total Mortalities

Postexposure

Hrs.

Days

0 - 4

1

2

3

4

5

6

7 - 14

M

F

M

F

M

F

M

F

M

F

M

F

M

F

M

F

Male

Female

Total

2034

0/5

0/5

0/10

3229

1

0/5

1/5

1/10

5126

2

2

0/5

4/5

4/10

8137

1

3

3

2

1

5/5

5/5

10/10

12918

5

5

5/5

5/5

10/10

The Acute Oral LD50 Values and 95% Confidence Limits

Male Rats: 6458 (5590 - 7462)

Female Rats: 4068 (3132 - 5284)

Combined Male and Female Rats: 5126 (4294 - 6118)

Slope

Male Rats: 1.66

Female Rats: 1.66

Combined Male and Female Rats: 1.66

Table 2: Body Weights obtained during 14 -day observation period

Dosage Level mg/kg	Individual Rat No.	Sex	Control Weight (grams)	7-Day Weight (grams)	14-Day Weight (grams)
2034	70485	Male	211	295	334
	70486	Male	231	272	286
	70487	Male	244	312	343
	70488	Male	248	296	323
	70498	Male	243	291	324
	70490	Female	214	248	256
	70491	Female	210	243	258
	70492	Female	208	242	273
	70493	Female	202	247	254
	70494	Female	200	224	243
3229	70354	Male	200	258	310
	70355	Male	221	245	292
	70356	Male	215	281	312
	70357	Male	201	264	324
	70358	Male	213	280	325
	70349	Female	212	234	226
	70350	Female	200	240	246
	70351	Female	214	238	260
	70352	Female	200	Died	Died
	70353	Female	216	252	241
5126	70364	Male	200	211	222
	70365	Male	201	244	308
	70366	Male	205	269	318
	70367	Male	202	225	258
	70368	Male	207	248	288
	70359	Female	200	235	216
	70360	Female	200	Died	Died
	70361	Female	201	Died	Died
	70362	Female	220	Died	Died
	70363	Female	210	Died	Died
8137	70374	Male	201	Died	Died
	70375	Male	203	Died	Died
	70376	Male	208	Died	Died
	70377	Male	205	Died	Died
	70378	Male	200	Died	Died
	70369	Female	210	Died	Died
	70370	Female	218	Died	Died
	70371	Female	220	Died	Died
	70372	Female	206	Died	Died
	70373	Female	204	Died	Died
12918	70384	Male	215	Died	Died
	70385	Male	200	Died	Died
	70386	Male	210	Died	Died
	70387	Male	200	Died	Died
	70388	Male	200	Died	Died
	70379	Female	204	Died	Died
	70380	Female	200	Died	Died
	70381	Female	210	Died	Died
	70382	Female	210	Died	Died
	70383	Female	202	Died	Died

 

Interpretation of results:

GHS criteria not met

Conclusions:

The presented studies finds that 1-Methyl-1-phenylethyl peroxyneodecanoate is not of acute oral toxicity and that GHS criteria are not met.

Executive summary:

In a primary acute oral toxicity study (similar to OECD 401), Charles River CD rats (5/sex/dose) were orally exposed to 2034, 3229, 5126, 8137 and 12918 mg/kg bw Cumyl peroxyneodecanoate (1-Methyl-1-phenylethyl peroxyneodecanoate, 90.2% purity), suspended in corn oil. Animals then were observed for 14 days. Due to mortality distribution, the oral LD₅₀ in rats in considered to be 6458 mg/kg bw for males, 4068 mg/kg bw for females and 5126 mg/kg bw for both sexes.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1992-10-9 to 1992-12-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

TEST MATERIAL
- Brand name: TRIGONOX 99-C75
- Batch No. 0509207222002
- CAS No.: 26748-47-0
- Purity: 75% Cumylperoxyneodecanoate in aromatic free mineral spirit (CAS No.: 26748-47-0 and 31807-55-3)
- Appearance: clear colorless liquid

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Akzo Chemicals International BV, Barcham Wuytierslaan 10, P.O. Box 975, 3800 AZ Amersfoort, The Netherlands; batch-no.: 0509207222002

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: freezer

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was prepared at the appropriate concentration in maize oil.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (U.K.) Limited, Margate, Kent, England
- Age at start of treatment: approx. 5 weeks
- Body weight at start of treatment: males 137 - 149 g, females 128 - 142 g
- Fasting period before study: Food was removed from the hoppers at approx. 15 hours on the day before dosing.
- Identification: tail tattoos
- Acclimatization: at least 5 days
- Housing: Animals were housed in stainless steel grid cages (Stephen Clark Fabrications Limited, Alva, Clackmannanshire, Scotland). The grid floor ensured rapid removal of waste material to undertray. Five animals of the same sex were accommodated in each cage.
- Diet: ad libitum, pelleted rodent diet (RM-1 S.Q.C., from Special Diets Services Limited, Witham, Essex, England); removal of food for approx. 21 hours before administration of test material until 3 hours after administration
- Water: ad libitum, tap water

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 21 °C
- Humidity (%): 36 - 55 % R.H.
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes per hour: 15 (without re-circulation)

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Clinical signs: Day 1: 1 h, 3 h and 5 h post-exposure; daily thereafter; Weighing: day before dosing and Day 1, 8 and 15
- Necropsy of survivors performed: Yes, all animals were sacrificed
- Other examinations performed: no

Statistics:

LD50 values and associated 95% confidence interval

Preliminary study:

Group of one male and one female rat given single oral administration of TRIGONOX 99-C75 at single dosage of 800 mg/kg bw, at constant volume-dosage of 10 mL/kg in maize oil. No deaths occured.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured. See also Table 1 in box 'Any other information on results incl. tables'.

Clinical signs:

Clinical signs as underactivity, staggering gait, piloerection and hunched posture on the day of dosing were observed. The animals were overtly normal by the following day.
For individual results, see Table 2 in box 'Any other information on results incl. tables'.

Body weight:

All animals achieved expected body weight gains.
See Table 4 in box 'Any other information on results incl. tables'.

Gross pathology:

Necropsy on day 15 revealed no significant macroscopic lesion.
See Table 5 in box 'Any other information on results incl. tables'.

Table 1: Mortality

Dosage (mg/kg bw)	Male	Female	Combined
2000	0/5	0/5	0/5

Table 2: Distribution of signs - MALE

Signs of reaction to treatment	Cage, sex and animal number X651 MALE					Number showing effect at time after dosing
						Hour					Day
	801	802	803	804	805	1/4	1/2	1	3	5	2		3		4		5		6		7		8		9		10		11		12		13		14		15
											a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a
Decedents: None
Animals survivingat Day 15
No abnormality detected						5	5				5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5
Underactivity	+	+	+	+	+				5	5
Staggering gait	+	+	+	+	+			5	5	5
Piloerection	+	+	+	+	+				5	5
Hunched posture	+	+	+	+	+				5	5
Total number of survivors: 5

+ Indicates an animal exhibiting a sign: a = am; p = pm

Table 3: Distribuion of signs FEMALE

Signs of reaction to treatment	Cage, sex and animal number X651 MALE					Number showing effect at time after dosing
						Hour					Day
	806	807	808	809	810	1/4	1/2	1	3	5	2		3		4		5		6		7		8		9		10		11		12		13		14		15
											a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a	p	a
Decedents: None
Animals survivingat Day 15
No abnormality detected						5	5				5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5
Underactivity	+	+	+	+	+			2	5	5
Staggering gait	+	+	+	+	+			5	5	5
Piloerection	+	+	+	+	+				5	5
Hunched posture	+	+	+	+	+			1	5	5
Total number of survivors: 5

Table 4: Individual body weights

Bodyweight (g)			Animal number and sex
			801M	802M	803M	804M	805M
Day		-1	149	137	139	147	141
Day		1	133	123	122	123	121
Day		8	214	192	199	203	189
Day		15	280	256	268	259	255
Increment			131	119	129	112	114
Mean of Increment							121
			806F	807F	808F	809F	810F
Day	-1		128	137	142	138	130
Day	1		116	119	127	121	117
Day	8		168	178	193	178	164
Day	15		196	207	223	196	184
Increment			68	70	81	58	54
Mean of increment							66

Table 5: Necropsy observation

Aminal number and sex	Died or Sacrificed	Time of death Day	Necropsy observation
801M	Sacrificed	15	External: No significant lesion Internal: No significant lesion
802M	Sacrificed	15	External: No significant lesion                Internal: No significant lesion
803M	Sacrificed	15	External: No significant lesion                Internal: No significant lesion
804M	Sacrificed	15	External: No significant lesion                Internal: No significant lesion
805M	Sacrificed	15	External: No significant lesion                Internal: No significant lesion
806F	Sacrificed	15	External: No significant lesion                Internal: No significant lesion
807F	Sacrificed	15	External: No significant lesion                Internal: No significant lesion
808F	Sacrificed	15	External: No significant lesion                Internal: No significant lesion
809F	Sacrificed	15	External: No significant lesion                Internal: No significant lesion
810F	Sacrificed	15	External: No significant lesion                Internal: No significant lesion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study conducted according to OECD guideline 401, fasted Sprague-Dawley rats (5/sex/dose) were given a single oral dose of TRIGONOX 99-C75 (1-Methyl-1-phenylethyl peroxyneodecanoate, 75% purity), suspended in maize oil, at a dose of 2000 mg/kg bw and were observed for 15 days. Due to the absence of mortality and low adverse clinical signs, the oral LD₅₀ in rats is considered to be greater than 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Guideline study

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978-04-04 to 1978-07-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

1 hour exposure instead of 4 hours

GLP compliance:

not specified

Test type:

traditional method

Limit test:

no

Specific details on test material used for the study:

- Name of the test material: SN-1-4462-71X
- Chemical name: cumyl peroxyneodecanoate
- Purity: 75.5% (0.19% Hydro, 896 ppm Cl)
- Appearance: pale yellow liquid

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS & ENVIRONMENTAL CONDITIONS
- Source: no data
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: 235-242 g (male rats), 200-214 g (female rats)
- Fasting period before study: no data
- Housing: The rats were housed individually in wire-mesh cages and were kept throughout the pre- and post-exposure periods in a temperature and humidity controlled room in accordance with standards outlined in the "Guide For the Care and Use of Laboratory Animals; DHEW No. (N.I.H. 74-23) 1974". During exposure, the rats were caged individually in compartmented wire-mesh exposure cages. The cages were placed in a 160-liter cubical, stainless steel and glass chamber. A constant chamber airflow was maintained by means of a rotary centrifugal air pump located at the exhaust side of the chamber. The chamber exhaust was filtered with an activated charcoal filter and a Cambridge Absolute® filter before being discharged outside of the laboratory.
- Diet (e.g. ad libitum): Purina Laboratory chow, ad libitum (except in the exposure chamber)
- Water (e.g. ad libitum): ad libitum (except in the exposure chamber)
- Acclimation period: 1 week

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

The vapors of the compound were generated by metering the liquid at the rate of 0.494 mL/min with a Harvard Infusion pump into a positive pressure atomizer located near the chamber air inlet at the top of the exposure chamber. An air pressure of 10 psig, with an air-flow rate of 8 L/min, was applied to the atomizer which aerosolized the liquid for rapid vaporization. The vapors and aerosols emerging from the atomizer were diluted by the incoming chamber air at the rate of 14 L/min to the desired concentration. The "metered" concentration of the compound (20.4 mg/L) in the chamber atmosphere was calculated from the ratio of the rate of liquid dissemination (449.5 mg/min*) to the rate of total chamber airflow (22 L/min). The total chamber airflow represents the volume of air ejected from the atomizer plus the volume of make-up air passing through the chamber per unit time.

*The specific gravity of the liquid was gravimetrically determined to be 0.91

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

1 h

Concentrations:

20.4 mg/L

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for toxic signs and mortility were made during and immediately following the 1 hour exposure period and twice daily thereafter for 14 days.
- Frequency of weighing: Individual body weights were recorded prior to the 1 hour exposure and periodically thereafter.
- Necropsy of survivors performed: yes

Statistics:

no data

Preliminary study:

n.a.

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 20.4 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Mortality:

None of the rats died in the experiment.

Clinical signs:

other: The immediate response of the rats to the experimental atmosphere was an increase of activity in preening. After several minutes of exposure, this activity decreased. After 20 minutes of exposure 50% of the rats exhibited slight dyspnea. At 30 minutes, al

Body weight:

A slight body weight loss was observed in the rats for 1-5 day post-exposure. By the end of the 14-day post-exposure, the body weights of all the rats exceeded those of the pre-exposure values. See Table 1 in box 'Any other information on results incl. tables'.

Gross pathology:

Gross pathological examination of the rats which were sacrificed at the end of the experimental period revealed gray patches on the lungs of 1 male rat and no compound related pathologic changes in the remaining 9 rats.

Table 1: Individual Body Weights

Individual body weights (in grams)
		Pre-exposure	Post-exposure (Days)
		0	1	3	5	7	14
Rat no.	Sex
1	M	235	220	232	262	286	346
2	M	240	225	240	260	285	328
3	M	238	224	236	258	276	320
4	M	235	221	238	258	271	300
5	M	242	224	236	255	272	295
6	F	200	192	200	211	218	236
7	F	200	202	205	212	226	228
8	F	210	192	222	211	224	240
9	F	214	200	210	220	229	250
10	F	210	199	200	207	224	232

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute inhalation study, Charles River CD rats were inhaled via whole-body exposure to 20.4 mg/L for 1 hour. No mortality occurred during the 14-day observation period. Based on the results, the LC50 is considered to be greater than 20.4 mg/L.

Executive summary:

In an acute inhalation toxicity study conducted similar to OECD 403, groups of Charles River CD rats (5/sex) were exposed by inhalation route to LUPERSOL 188M75 containing 75.5% cumyl peroxyneodecanoate (0.19% Hydro; 896 ppm Cl-) for 1 hour to whole body at a concentration of 20.4 mg/L. Animals then were observed for 14 days. No mortality occurred. During exposure, animals showed an increase of activity in preen in and all rats exhibited slight dyspnea and some rats exhibited salivation. One rat exhibited eye squint on day 1 post-exposure. A slight body weight loss was observed in the rats for day 1 to 5 post-exposure. In one male rat, grey patches on the lungs were observed. Based on the results, the LC50 is greater than 20.4 mg/L.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Comparable to guideline study

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977-09-02 to 1978-02-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

only 2 animals per dose group were used

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

- Name: Cumyl peroxyneodecanoate (SN-1-4462-71)
- Purity: 90.2%
- Appearance: viscous yellowish liquid
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Pennwalt Corporation (Lucidol Division), Buffalo, New York

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sweetwater Farm, Hillsboro, Ohio
- Weight: 2343 - 3000 g
- Housing: Animals were housed individually in hanging wire-mesh cages
- Water: ad libitum
- Diet: ad libitum; Purina Rabbit Chow
- Temperature and humidity controlled quarters

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

The hair was removed from the back of each rabbit (20 – 30% of the body surface) with an electric clipper. The test material

Duration of exposure:

24 h

Doses:

500, 1250, 3150, 7940 and 19800 mg/kg bw

No. of animals per sex per dose:

1 male and 1 female rabbits

Control animals:

no

Details on study design:

TEST SITE
- Area of exposure: Back; on 20-30% of the body surface the hair was removed.
- % coverage:
- Type of wrap if used: The area of application was wrapped with gauze bandaging and occluded with Saran Wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with tepid tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Dose volume: 500, 1250, 3150, 7940 and 19800 mg/kg

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 940 - < 19 800 mg/kg bw

Based on:

test mat.

Mortality:

The two rabbits at the 19800 mg/kg dosage level died. None of the other rabbits died during the 14-day observation period.

Clinical signs:

No data

Body weight:

Body weight gain was noted for all surviving animals during the test period, except for one male at 500 mg/kg and one female at 7940 mg/kg bw.
For individual results see Table 1 in box 'Any other information on results incl. tables'.

Gross pathology:

No data

Table 1: Body Weights: The following body weights were obtained during the 14-day observation period

Dosage level mg/kg	Individual rabbit no.	Sex	Control Weight (grams)	7-Day weight (grams)	14-day weight (grams)
500	30237	Male	2575	2693	2508
	30238	Female	2720	2844	2978
1250	30331	Male	2955	3038	3215
	30254	Female	3000	3226	3465
3150	30259	Male	2841	2835	3081
	30340	Female	2786	2665	2946
7940	30339	Male	2770	2668	2874
	30338	Female	2446	2251	2326
19800	30327	Male	2669	Died	Died
	30336	Female	2343	Died	Died

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, the acute dermal LD50 of 1-methyl-1-phenylethyl peroxyneodecanoate (90.2% purity) was found to be greater than 7940 mg/kg but less than 19800 mg/kg.

Executive summary:

In an acute dermal toxicity study (similar to OECD 402), groups of New Zealand White rabbits (1/sex/dose) were dermally exposed to Cumyl peroxyneodecanoate (90.2% purity) in for 24 hours to 20 – 30% of the body surface at doses of 500, 1250, 3150, 7940 and 19800 mg/kg bw. Animals then were observed for 14 days. Under the conditions of this study, the acute dermal LD₅₀ of 1 -Methyl-1-phenylethyl peroxyneodecanoate was found to be greater than 7940 mg/kg but less than 19800 mg/kg.

Body weight gain was noted for all surviving animals during the test period, except for one male at 500 mg/kg and one female at 7940 mg/kg bw.

No changes in body weight gain was observed. Mortality occurred at the highest dose level (19800 mg/kg bw) in both animals. None of the other rabbits died during the 14-day observation period.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

7 940 mg/kg bw

Quality of whole database:

Comparable to guideline study

Additional information

For 1-Methyl-1-phenylethyl peroxyneodecanoate (target substance), suitable data are available to assess the acute toxicity. In an acute oral in vivo toxicity study conducted similar to OECD 401, Charles River CD rats (5/sex/dose) were orally exposed to 2034, 3229, 5126, 8137 and 12918 mg/kg bw Cumyl peroxyneodecanoate (target substance, 90.2% purity). In this study, the oral LD50 in rats in considered to be 5126 mg/kg bw. In a second available acute oral in vivo toxicity study conducted according to OECD 401, Sprague-Dawley rats were given a single oral dose of TRIGONOX 99-C75 (target substance, 75% purity). In this study, the oral LD50 in rats is considered to be greater than 2000 mg/kg bw.

In an acute inhalation toxicity study similar to OECD 403, Charles River CD rats were exposed by inhalation route to LUPERSOL 188M75 containing 75.5% cumyl peroxyneodecanoate (0.19% Hydro; 896 ppm Cl^-) for 1 hour via whole body exposure at a concentration of 20.4 mg/L. No mortality occurred during the 14-day observation period.

In an acute dermal toxicity study conducted similar to OECD 402, groups of New Zealand White rabbits (three/sex) were dermally exposed to Cumyl peroxyneodecanoate (90.2% purity) for 72 hours at doses of 500, 1250, 3150, 7940 and 19800 mg/kg bw. Based on the results, the dermal LD50 was considered to be within < 19800 and > 7940 mg/kg bw.

Justification for classification or non-classification

Based on the available data the target substance 1-metyl-1-phenylethyl peroxyneodecanoate does not warrant classification for acute toxicity. LD50 values for the dermal and oral route were above the limit values of the relevant OECD guidelines. In an acute inhalation study no mortality occurred and the LC50 is considered to be greater than 20.4 mg/L.